EP3290432A4 - High performance liquid chromatography method for polypeptide mixtures - Google Patents
High performance liquid chromatography method for polypeptide mixtures Download PDFInfo
- Publication number
- EP3290432A4 EP3290432A4 EP15890235.3A EP15890235A EP3290432A4 EP 3290432 A4 EP3290432 A4 EP 3290432A4 EP 15890235 A EP15890235 A EP 15890235A EP 3290432 A4 EP3290432 A4 EP 3290432A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- high performance
- liquid chromatography
- performance liquid
- chromatography method
- polypeptide mixtures
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
- B01D15/16—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
- B01D15/166—Fluid composition conditioning, e.g. gradient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/03—Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/32—Bonded phase chromatography
- B01D15/325—Reversed phase
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
- B01D15/361—Ion-exchange
- B01D15/362—Cation-exchange
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
- B01D15/361—Ion-exchange
- B01D15/363—Anion-exchange
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
- G01N21/33—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using ultraviolet light
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/62—Detectors specially adapted therefor
- G01N30/74—Optical detectors
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/86—Signal analysis
- G01N30/8624—Detection of slopes or peaks; baseline correction
- G01N30/8631—Peaks
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/18—Ion-exchange chromatography
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
- G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
- G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
- G01N2030/8831—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Analytical Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Physics & Mathematics (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Engineering & Computer Science (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Biomedical Technology (AREA)
- Spectroscopy & Molecular Physics (AREA)
- Biophysics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Epidemiology (AREA)
- Gastroenterology & Hepatology (AREA)
- Genetics & Genomics (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Food Science & Technology (AREA)
- Bioinformatics & Computational Biology (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- Psychiatry (AREA)
- General Chemical & Material Sciences (AREA)
- Hospice & Palliative Care (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP19198022.6A EP3613756B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
EP19198009.3A EP3603764B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/CN2015/077690 WO2016172855A1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
Related Child Applications (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19198022.6A Division-Into EP3613756B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
EP19198022.6A Division EP3613756B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
EP19198009.3A Division EP3603764B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
EP19198009.3A Division-Into EP3603764B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
Publications (3)
Publication Number | Publication Date |
---|---|
EP3290432A1 EP3290432A1 (en) | 2018-03-07 |
EP3290432A4 true EP3290432A4 (en) | 2019-03-27 |
EP3290432B1 EP3290432B1 (en) | 2022-03-30 |
Family
ID=57198918
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19198022.6A Active EP3613756B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
EP19198009.3A Active EP3603764B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
EP15890235.3A Active EP3290432B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19198022.6A Active EP3613756B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
EP19198009.3A Active EP3603764B1 (en) | 2015-04-28 | 2015-04-28 | High performance liquid chromatography method for polypeptide mixtures |
Country Status (5)
Country | Link |
---|---|
US (1) | US10330650B2 (en) |
EP (3) | EP3613756B1 (en) |
JP (1) | JP6676072B2 (en) |
CN (3) | CN112649537B (en) |
WO (1) | WO2016172855A1 (en) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111060635A (en) * | 2019-11-27 | 2020-04-24 | 吉尔生化(上海)有限公司 | Analysis and detection method of carbetocin |
CN111138516B (en) * | 2020-01-10 | 2023-04-25 | 大理大学 | A kind of Vespa peptide and its preparation method and application |
CN112858522B (en) * | 2021-02-20 | 2022-09-20 | 重庆工贸职业技术学院 | A method for separation and determination of heteroamino acids in high-purity valine by high performance liquid chromatography |
CN113009014B (en) * | 2021-02-24 | 2023-04-07 | 上海旭东海普药业有限公司 | High performance liquid detection method for 2-methoxy-5-fluorouracil impurities |
CN113720941B (en) * | 2021-09-18 | 2023-03-24 | 广东丸美生物技术股份有限公司 | Detection method of polypeptide in skin care product raw material or skin care product and high performance liquid chromatography detection method of polypeptide |
CN114280179B (en) * | 2021-12-22 | 2024-03-15 | 北京美福润医药科技股份有限公司 | Pretreatment of exenatide and detection method of isomer in His amino acid eluent obtained by pretreatment |
CN114384194B (en) * | 2021-12-28 | 2023-09-22 | 湖南中晟全肽生化有限公司 | Method for high-flux detection of polypeptide |
CN114609286A (en) * | 2022-03-18 | 2022-06-10 | 浙江理工大学 | A kind of method for detecting isophthalic acid content of polyester fabric |
KR102742623B1 (en) * | 2022-04-07 | 2024-12-16 | 에쓰대시오일 주식회사 | Method and device for measuring the amount of rubber in impact polypropylene |
CN115078592B (en) * | 2022-07-15 | 2024-01-23 | 广东广纳安疗科技有限公司 | Detection method of acrylamide monomer and application thereof |
CN115586288B (en) * | 2022-10-08 | 2024-07-26 | 广州朗圣药业有限公司 | High performance liquid chromatography detection method for SZFZ-A content in SZFZ-A-containing composition |
CN115656391B (en) * | 2022-12-12 | 2023-04-07 | 哈尔滨吉象隆生物技术有限公司 | Method for detecting impurities contained in teriparatide |
CN116429950B (en) * | 2023-06-07 | 2023-08-11 | 成都佩德生物医药有限公司 | Method for analyzing related substances of polypeptide PD-DP-005 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2004024866A2 (en) * | 2002-09-11 | 2004-03-25 | Genentech, Inc. | Protein purification |
WO2007127977A2 (en) * | 2006-04-28 | 2007-11-08 | Momenta Pharmaceuticals, Inc. | Methods of evaluating peptide mixtures |
Family Cites Families (24)
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IL119989A0 (en) * | 1997-01-10 | 1997-04-15 | Yeda Res & Dev | Pharmaceutical compositions for oral treatment of multiple sclerosis |
JPH11271294A (en) * | 1998-03-23 | 1999-10-05 | Mitsubishi Chemical Corp | Spherical porous cross-linked polymer particle, and preparation thereof |
JP2002517406A (en) * | 1998-06-01 | 2002-06-18 | ジェネンテック・インコーポレーテッド | Separation of protein monomers from aggregates by using ion exchange chromatography |
IL141021A0 (en) * | 1998-07-23 | 2002-02-10 | Yeda Res & Dev | Treatment of autoimmune conditions with copolymer 1 and related copolymers |
ES2369642T3 (en) * | 1998-09-25 | 2011-12-02 | Yeda Research And Development Co., Ltd. | POLYPEPTIDES RELATED TO COPOLIMER 1 FOR USE AS MOLECULAR WEIGHT MARKERS AND FOR THERAPEUTIC USE. |
CN1591005A (en) * | 2003-09-02 | 2005-03-09 | 浙江大学 | Linkage type cation chromatographic column and its preparation method |
US7972780B2 (en) * | 2004-02-18 | 2011-07-05 | Guy's And St. Thomas' Nhs Foundation Trust | ITPase gene polymorphisms associated with adverse drug reactions to azathioprine therapy |
WO2007142578A1 (en) * | 2006-06-09 | 2007-12-13 | Ge Healthcare Bio-Sciences Ab | Method of separating monomeric protein (s) |
EP2277050B2 (en) | 2008-04-16 | 2022-09-28 | Momenta Pharmaceuticals, Inc. | Analysis of amino acid copolymer compositions |
AR076664A1 (en) * | 2009-05-08 | 2011-06-29 | Scinopharm Taiwan Ltd | METHOD FOR ANALYZING PEPTIDIC MIXTURES WITH MASS SPECTOMETRY |
CA2766571A1 (en) * | 2009-07-09 | 2011-02-24 | Biocon Limited | A preparative non-linear gradient based chromatographic method and purified products thereof |
CN102713599A (en) * | 2010-01-25 | 2012-10-03 | 株式会社日立高新技术 | Liquid chromatograph and liquid feeder for liquid chromatograph |
EA201201227A1 (en) * | 2010-03-03 | 2013-04-30 | Бёрингер Ингельхайм Интернациональ Гмбх | Biparate-β-beta-binding polypeptides |
CA2806997A1 (en) * | 2010-07-29 | 2012-02-02 | Dr. Reddy's Laboratories Ltd. | Glatiramer acetate molecular weight markers |
US9029507B2 (en) * | 2011-02-14 | 2015-05-12 | Usv Limited | Copolymer-1, process for preparation and analytical methods thereof |
EP2819788B1 (en) * | 2012-02-27 | 2018-08-22 | Amunix Operating Inc. | Xten conjugate compositions and methods of making same |
CN104098655B (en) * | 2013-04-09 | 2018-01-30 | 深圳翰宇药业股份有限公司 | Target polypeptide in mass spectrum for synthesizing acetic acid copaxone |
CN103265624B (en) * | 2013-05-27 | 2015-04-22 | 成都圣诺生物制药有限公司 | Method for preparing copaxone |
CN103335873B (en) | 2013-06-04 | 2017-04-19 | 深圳翰宇药业股份有限公司 | Method for measuring chloride ion content of amino acid-N-formic anhydride |
JP6367195B2 (en) * | 2013-07-17 | 2018-08-01 | 積水メディカル株式会社 | Gradient liquid feeder in sample analyzer |
CN104371012A (en) * | 2013-08-12 | 2015-02-25 | 深圳翰宇药业股份有限公司 | Synthesis method of glatiramer acetate |
CN104297404B (en) * | 2014-09-26 | 2016-08-24 | 深圳翰宇药业股份有限公司 | A kind of for measuring the method for piperidines impurity content in acetic acid copaxone sample |
WO2016176649A1 (en) * | 2015-04-30 | 2016-11-03 | Teva Pharmaceutical Industries Ltd. | Method of determining the molecular weight distribution of glatiramer acetate using multi-angle laser light scattering (malls) |
ES2707500T3 (en) * | 2015-11-23 | 2019-04-03 | Chemi Spa | Analysis by RP-HPLC of mixtures of complex polypeptides |
-
2015
- 2015-04-28 EP EP19198022.6A patent/EP3613756B1/en active Active
- 2015-04-28 US US15/559,428 patent/US10330650B2/en active Active
- 2015-04-28 EP EP19198009.3A patent/EP3603764B1/en active Active
- 2015-04-28 CN CN202011638347.0A patent/CN112649537B/en active Active
- 2015-04-28 EP EP15890235.3A patent/EP3290432B1/en active Active
- 2015-04-28 CN CN202011643350.1A patent/CN112649538B/en active Active
- 2015-04-28 CN CN201580079194.1A patent/CN107531750B/en active Active
- 2015-04-28 WO PCT/CN2015/077690 patent/WO2016172855A1/en active Application Filing
- 2015-04-28 JP JP2017556727A patent/JP6676072B2/en active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2004024866A2 (en) * | 2002-09-11 | 2004-03-25 | Genentech, Inc. | Protein purification |
WO2007127977A2 (en) * | 2006-04-28 | 2007-11-08 | Momenta Pharmaceuticals, Inc. | Methods of evaluating peptide mixtures |
Non-Patent Citations (1)
Title |
---|
See also references of WO2016172855A1 * |
Also Published As
Publication number | Publication date |
---|---|
CN107531750A (en) | 2018-01-02 |
EP3603764B1 (en) | 2022-03-30 |
CN112649537B (en) | 2024-03-29 |
EP3290432B1 (en) | 2022-03-30 |
CN112649538A (en) | 2021-04-13 |
EP3603764A1 (en) | 2020-02-05 |
EP3290432A1 (en) | 2018-03-07 |
JP2018515766A (en) | 2018-06-14 |
EP3613756A1 (en) | 2020-02-26 |
EP3613756B1 (en) | 2024-02-21 |
CN112649537A (en) | 2021-04-13 |
CN107531750B (en) | 2021-03-16 |
WO2016172855A1 (en) | 2016-11-03 |
JP6676072B2 (en) | 2020-04-08 |
US10330650B2 (en) | 2019-06-25 |
CN112649538B (en) | 2024-03-29 |
US20180080909A1 (en) | 2018-03-22 |
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